- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542838
Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis
March 30, 2021 updated by: Sorrento Therapeutics, Inc.
Phase 1b Double-blind Study to Assess the Safety, Tolerability and Preliminary Efficacy of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Pain Due to Moderate to Severe Osteoarthritis of the Knee
This study evaluates the safety of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is to evaluate the safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).
It is also to assess the preliminary efficacy of resiniferatoxin to relieve knee pain when walking.
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Snibbe Orthopedics
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Florida
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Miami, Florida, United States, 33136
- University of Miami/Sylvester Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
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Texas
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Houston, Texas, United States, 77004
- Hermann Drive Surgical Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Age: 35 years to 85 years
- Diagnosis of moderate to severe pain due to OA: Moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria
- BMI < 45 kg/m2
- Pain in the target knee has been treated with at least 2 analgesic agents, including at least one NSAID
- Prior failure in at least two prior analgesic agents (at least one NSAID)
- Willing to abstain from other intra-articular treatments of the knee or any knee surgery for at least 24 weeks after treatment
- Ability to comply with the study and give informed consent
- If on an opioid medication, stable dose for at least 4 weeks prior to injection with no increase in dose leading up to study injection
- If on NSAIDs, be on a stable analgesic regimen for at least 4 weeks prior to injection
- If on pain regimens other than opioid medication or NSAIDs, be on a stable regimen for at least 30 days
- Is in good general health and is considered to have a physical status that is American Society of Anesthesiologists (ASA) category ≤ 3
- Able to comply with study procedures, including the recording of daily questionnaires
Exclusion Criteria:
- Has evidence or history of a coagulopathy or hemostasis problem at Screening or Baseline (Day 1)
- Treatment knee injections with corticosteroids within 30 days or hyaluronic acid within 3 months prior to the procedure
- If on opioid analgesics, an upper limit of 30 mg/day of oral morphine sulfate, 20 mg/day of oxycodone, 30 mg/day of hydrocodone, or 300 mg/day of tramadol, or equivalent
Any of the following lab abnormalities within one week of the treatment day:
- Platelet count <100,000 cells/mm3
- Total neutrophil count <1500 cells/mm3
- Serum creatinine ≥ 1.5 x ULN
- Alanine aminotransferase (ALT) > 3.0 x ULN
- Aspartate aminotransferase (AST) > 3.0 x ULN
- Alkaline phosphatase > 2.0 ULN
- Bilirubin > 1.5 x ULN
- INR > 1.5 x ULN
- Temperature ≥ 100.4°F or other evidence of an infection
- Concurrent use of opioids for indications other than knee pain
- History of substance abuse
- Has an allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin or radiographic contrast agents
- Female subjects who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding
- Subjects with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments
- Subjects who have participated in a clinical study of an investigational drug within 4 half-lives of Screening or are scheduled to receive and investigational agent while participating in this study
- Sensory peripheral neuropathy that is CTCAE Grade 2 or higher at Screening
- Arterial or venous thrombi, myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within 12 months prior to Screening
- Evidence or history of any hemorrhage or bleeding event that is higher than CTCAE Grade 1 within 4 weeks prior to injection.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C. Positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
- Concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint
- Subjects with significant pain in other joints may be excluded at the discretion of the investigator
- Subject has undergone arthroscopic or open surgery to the knee within 6 months of the planned injection day
- Subject has undergone replacement surgery of the treatment knee
- Presence of surgical hardware or other foreign bodies in the treatment knee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Resiniferatoxin
Resiniferatoxin is administered as a one-time dose, intra-articularly at a dose level of 5ug, 12.5ug, 20ug, 25ug, or 30ug.
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Resiniferatoxin is a compound purified from natural sources.
Other Names:
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Placebo Comparator: Saline
Saline is administered as a one-time dose, intra-articularly.
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Saline is a normal physiological solution
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety measurement
Time Frame: baseline through week 52
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Incidence and severity of adverse events
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baseline through week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of knee pain when walking
Time Frame: baseline through week 52
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Improvement in pain score versus baseline using the WOMAC Osteoarthritis Index question A1 (pain on walking, 11-point numerical rating scale)
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baseline through week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2018
Primary Completion (Actual)
April 13, 2020
Study Completion (Actual)
February 11, 2021
Study Registration Dates
First Submitted
May 7, 2018
First Submitted That Met QC Criteria
May 18, 2018
First Posted (Actual)
May 31, 2018
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTVA OA-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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